Percutaneous fixator method of insertion

ABSTRACT

The present invention provides a technique for percutaneous intramedullary fixation. A protective outer sheath is provided for internal fixation of the proximal tibia. Additionally, a unique intramedullary plate is provided that is adapted for percutaneous insertion into the intramedullary canal of a long bone. A plate holder is also provided that may be utilized through the outer sheath to drive and position a fixation plate within the intramedullary canal.

CROSS REFERENCE

This application claims priority from U.S. Provisional patentapplication Ser. No. 60/454,826, filed on Mar. 14, 2003, and entitled“PERCUTANEOUS FIXATOR AND METHOD OF INSERTION”

BACKGROUND

The present invention relates to skeletal fixation. In one aspect, itprovides improved instruments, fixation members and methods of insertionfor tibial fixation utilizing an intra-articular insertion.

Tibial fixation utilizing elongated plates or rods disposed in theintramedullary canal or plating on the tibia cortex has been previouslyperformed to provide fixation of the proximal tibia. In a traditionalapproach, a plate is placed on the periosteal cortex through an open orlimited open surgical approach. Alternatively, the knee joint is flexedso that the surgeon can gain access to the proximal portion of the tibiaintramedullary canal. In previous intramedullary approaches, the patellais moved laterally to provide direct access to the proximal portion ofthe tibia. This technique is known as a medial-patella tendon approach.In this procedure, much of the trauma associated with the surgicalaccess to the proximal portion of the tibia occurs in moving the patellalaterally and posteriorly because it blocks access to the desired entrysite.

SUMMARY OF THE INVENTION

The present invention provides a method for percutaneous insertion of afixation member for internal fixation from a supra-patella approach tothe tibia. In one aspect of the invention, a protective sheath ispositioned with a proximal portion positioned above (supra) the patellaadjacent the femur and a distal end portion adjacent the proximal end ofthe tibia. In a preferred embodiment of the method of the presentinvention, an obturator is provided that is sized to be received withinthe protective sheath. The obturator is advanced from the supra patellaaccess site to adjacent the tibia and the protective sheath is advancedover the obturator. In one aspect, a fixation member is joined to theproximal tibia after passing through the protective sheath. In a morepreferred aspect, after gaining surgical access to the intramedullarycanal of the tibia, a fixation member is advanced through the sheath andinto the proximal portion of the intramedullary canal of the tibia. In apreferred aspect, screws or other fixation members are passed throughthe fixation member, such as a plate or a rod, to lock it andsurrounding bone in a fixed position.

In another aspect of the present invention, a protective sheath isprovided for percutaneous proximal tibial fixation. In one aspect, thesheath includes a distal end with a tapered tip. In another aspect, thedistal end includes a radiopaque marker. More preferably, the taperedtip on the distal portion of the sheath is formed to substantially matchthe external geometry of the proximal tibia. In an alternativeconstruction, the sheath may taper from a first diameter at its proximalend to a second smaller diameter at its distal end. Still further, theprotective sheath may include a distal end adapted for fixedly engagingthe bone of the tibia. In one preferred aspect, anchor pins are providedto engage the bone. In an alternative preferred aspect, the externalsurface of the distal end of the protective sheath includes externalroughening including but not limited to, threads, ridges, knurling,teeth or grooves.

In yet another aspect of the present invention, a fixation plate isprovided that is configured for passage through a sheath forpercutaneous implantation. More specifically, in a preferred aspect, theplate includes an internal passage extending along its length adapted toreceive a guiding member. In a preferred aspect, the channel is insubstantial alignment with the longitudinal axis of the plate. In stilla further preferred aspect of the present invention, the percutaneouslyinserted plate includes a proximal end adapted for engagement with anelongated insertion tool and a distal end configured for atraumaticinsertion within the patient. In a more preferred embodiment, the distalend of the plate includes a first curvature along its width defining aninsertion nose and a second curvature along its thickness presenting arounded surface for engagement with the adjacent tissue.

In still a further aspect of the present invention, a kit is providedfor percutaneous fixation member implantation. In a preferred aspect,the kit includes a protective sheath having an end for engagement with along bone and an opposite free end. The kit further includes one or morefixation plates or rods adapted for sliding movement within the sheath.The kit may additionally include a fixation plate holder having amechanism for releasably attaching to the plate and a length sufficientto position the fixation plate beyond the distal end of the sheath whileat least a portion of the gripping tool extends beyond the free end ofthe sheath.

The present invention also provides a technique to permit percutaneousfixator insertion utilizing image-guided surgical techniques. Morespecifically, an obturator and/or a protective sheath may be providedwith a reference marker identifiable by an image-guided surgery system.Additionally, in a preferred aspect a guide wire is also fitted withinan image-guided sensor to denote its location within the bone ofinterest. In this technique, the plate gripping tool may also include areference marker such that when the plate is fixably attached to thegripping tool, the reference marker denotes the location and orientationof the plate as registered by the image-guided surgical computers. Inthis manner, a surgeon may specifically identify the orientation of theguide wire and surrounding protective sheath to determine the trajectoryof implantation. This may be determined through sequential x-ray imagingor other imaging techniques or by utilizing pre-defined images storedwithin a computer aided image-guided surgery system. After determinationof the proper trajectory, a cutting tool or broach may be advancedwithin the guide sleeve and preferably guided by the guide wire todefine an aperture extending into the intramedullary canal within thebone of interest. The cutting tool may then be withdrawn. A fixationplate may be gripped by an insertion tool and advance within the guidesheath to the predetermined position within the patient. It will beunderstood that the use of image-guided reference markers on theinsertion tool may assist the surgeon in determining the orientationwithin the patient and the proper location extending along the bone.Additionally, the image-guided reference markers may assist the surgeonwhen placing nails through the bone and through the apertures in thefixation plate.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a human knee joint.

FIGS. 2A-2E illustrate a protective sheath in accordance with one aspectof the present invention.

FIGS. 3A-3C illustrate an intramedullary fixation member in accordancewith another aspect of the present invention.

FIG. 4 illustrates a fixation plate gripping tool.

FIG. 5 is a stylized side view of a human knee joint showing the suprapatella insertion of a protective sheath according to the presentinvention.

FIG. 6 is a perspective view of the protective sheath associated withthe knee joint of FIG. 1.

FIG. 7 is a perspective view of a knee joint during insertion of anintramedullary fixation plate in accordance with the present invention.

FIG. 8 is a perspective view showing the intramedullary fixation plateimplanted within the intramedullary canal of a human tibia andassociated fixation screws.

FIG. 9 is a partial cross-sectional view of the tibia of FIG. 8.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention provides improved techniques, instruments andinternal fixation devices permitting percutaneous fixation within theintramedullary canal of the long bone. In a preferred aspect, theinstrument technique and fixation devices may be utilized for plating ofthe proximal tibia. FIG. 1 illustrates a stylized human knee jointhaving a femur F joined to tibia T by patella P and the associatedligaments. Femur F includes a channel C through which the patella movesduring flexion and extension of the knee joint. In a similar manner,tibia T includes a implantation site V at its proximal most portion. Itwould be understood, that the joint J normally includes cartilage toprevent or limit the contact between femur F and tibia T.

Referring now to FIGS. 2A through 2C, there is shown a protective sheathin accordance with one aspect of the present invention. Sheath 30includes a proximal end 32 and an opposite distal end 34. Distal end 34includes an extreme distal portion 38 having a blunt nose adapted to theengaged tissue in an atraumatic fashion. Tapered surface 36 extends fromblunt nose 38 on long side wall 39 to short sidewall 37. Surface 36 anda similar surface on the opposite side may also assist the protectivesheath 30 during insertion by mobilizing adjacent soft tissue to extendaround the exterior of the guide sleeve rather than protrude within theinternal passage 42. Additionally, distal end 34 is configured tosubstantially mimic and mate with the implantation site V of tibia Tshown in FIG. 1. Distal portion 34 is also provided with a radiopaquemarker 40. In a preferred aspect, protective sheath 30 is made from aradiolucent material such that x-ray or other imaging of the surroundingbone structures substantially unobstructed by its presence. Radiopaquemarker 40 permits the user to determine where distal portion 34 islocated within the patient and when it has been securely positionedagainst the proximal portion of the tibia. While the protective sheathof FIG. 2A is shown with substantially parallel side walls 37 and 39extending from the proximal portion to the distal portion, it will beunderstood that the proximal portion 32 may have an opening defining afirst diameter and the distal portion 34 may have an opening defining asecond diameter, wherein the first diameter is substantially larger thanthe second diameter. In another preferred aspect, the change from thefirst large diameter to the second smaller diameter may extend along thelength in a substantially continuous manner to define a taperingprotective sheath. As shown in FIG. 2D, anchoring pins 41 and 43 mayextend along the length of the sheath 30. The distal ends of the pinsmay be withdrawn into the tube during sheath insertion and extended intothe bone when the sheath is properly positioned. FIG. 2E illustrates aseries of externally projecting ridges 45 that may ease insertion of thesheath into the patient but inhibit removal of the sheath fromsurrounding bone or soft tissue.

Referring now to FIGS. 3A through 3C, there is shown an intramedullaryfixation member in accordance with another aspect of the presentinvention. Fixation plate 10 has a proximal end 18 and a distal portion20. Distal portion 20 includes a leading tip 21 and a lateral transition22 that extends from leading tip 21 to the main body of plate 30transitioning the width of the plate adjacent the leading tip in acontinuous manner to the full width of the main body of plate 10. In onepreferred aspect, the plate has a width of approximately 8 to 16 mm.Additionally, as shown in FIG. 3B, in the side view, it is apparent thatthe preferred aspect thickness transition area 23 extends from leadingtip 21 to the main body of plate 10 such that the thickness of the plateincreases from the leading tip in a substantially continuous manneruntil it approximates the width of the main body of plate 10. Plate 10includes a plurality of fixation apertures along its length such asthose shown at reference numbers 12 and 14. It will be appreciated thatthe placement and orientation of the screw apertures may be dependentupon the particular medical indication. More specifically, in theillustrated embodiment the longitudinal axis L₁ of plate 10 issubstantially perpendicular to the longitudinal axis of L₃ of fixationaperture 12. However, it will be appreciated that in many applicationsthe longitudinal axis L₃ may be set at a specific angle with respect tolongitudinal axis L₁ such that the fixation screw or other fixationnumber extends at a non-perpendicular orientation with respect to plate10.

Referring now to FIG. 3C, plate 10 includes a longitudinal bore 16extending along substantially its entire length. As will be illustratedand described further herein, bore 16 is sized to receive a guide wiremember along its length. While an internal bore 16 is shown that extendsalong the substantial length of plate 10, it will be appreciated that asimilar guiding feature may be implemented utilizing a fixture externalto the plate such that it can guide along a guide member during theimplantation process.

Referring now to FIG. 4, there is shown a percutaneous surgical tooladapted for implantation of an intramedullary plate. Plate holder 50includes an inner shaft 54 having a hook 52 at its distal end. Innershaft 54 includes a series of external threads 56 disposed adjacent theproximal end. Additionally, a handle 58 is provided at the proximal endto facilitate rotation of the plate holder 50. While a handle is shownfor the purpose of illustration, it will be appreciated that an internalor external driving pattern may be provided at the proximal end ofinternal shaft 54 such that a tool may be engage the shaft to facilitaterotation. Inner shaft 54 is disposed within outer tube 60. Outer tube 60has a ring 61 pivotally mounted on its proximal end. Ring 61 includes aseries of internal threads 62 configured and adapted for threadedengagement with external threads 56. A portion of plate 10 is shown incross section with hook 52 extending through fixation aperture 14. Thedistal end 64 of plate holder 50 includes a socket 66 adapted andconfigured to substantially mate with proximal end 18 of plate 10. Itwill be appreciated that as ring 61 is rotated with respect to innershaft 54 to retract the distal portion into the outer tube 60, hook 52will cause proximal end 18 to positively seat within socket 66. In aprepared aspect, it is intended that the engagement between socket 66and proximal end 18 will permit substantial force to be applied alongplate holder 50 both urging the plate forward along the longitudinalaxis of the plate and permitting the adjustment of the rotationalorientation of the plate about its longitudinal axis. Further, aseparate aperture, recess or other structure may be provided on theplate to mate with an alternative plate holder

Referring now to FIG. 5, there is shown a stylized human knee joint witha femur F, tibia T, patella P and the intervening joint J. In apreferred aspect of the invention, an obturator 70 is inserted throughthe patient's skin S above the patella P, in a supra-patella fashion.The obturator extends along the femur F under the patella P across thejoint J and to the proximal portion of the tibia. As can be seen in FIG.5, femur F and tibia T are in substantial alignment as the patient's legis in the fully extended position. Thus, it is clear that the patient'sbones are in a properly aligned position and in subsequent steps boneportions may be fixed to maintain that position during the healingprocess. Additionally, in this extended position, the patella tendonsare relatively relaxed permitting atraumatic movement of the patellalaterally and/or anteriorly. X-rays or other images may be taken todemonstration that obturator 70 is properly aligned within the patient'sbone. Protective sheath 30 may then be advanced over guide wire 70through the patient's skin along the femur and into the joint area J.Alternatively, the obturator and sheath may be advanced into the patientas a unit. The obturator may include a central bore for receiving aguide member 69. Preferably, the obturator will match the internaldiameter of the sheath 30 to facilitate proper positioning and preventtissue from entering the internal bore 42. The obturator may bewithdrawn after the sheath is positioned. It will be appreciated that atthis point or prior to placing the guide member, a surgeon may evaluatethe contents of the joint space through the sheath 30 and evacuate anydebris or damaged tissue prior to further surgical steps.

The distal end 34 of protective sheath 30 may be advanced until it is insubstantial alignment and/or engagement with the proximal end of tibiaT. In preferred aspects, the distal end 34 is configured tosubstantially mate with the implantation site V defined in the outersurface of the proximal tibia. Further imaging may be utilized to showthat radiopaque marker 40 is aligned in the proper position with respectto the adjacent boney structures. In one aspect of the procedure, theouter surface of protective sheath 30 may lie within at least a portionof channel C of femur F. Additionally, obturator 70 may include areference marker 72 that may be utilized by an image-guided surgerysystem to provide a reference for the surgeon in its placement and lateruse. Additionally, outer sheath 30 may also include a reference marker31 that may be utilized with an image-guided surgery system foralignment orientation within the patient.

Turning now to FIG. 6, there is shown a human knee joint in a partialcross sectional perspective view with the outer sheath 30 positionedwithin the implantation site V of the proximal tibia. As shown in FIG.6, radiopaque marker 40 is in substantial alignment with the adjacentboney structure of the implantation site V. Thus, it is anticipated thatdistal end 34 will be in substantial engagement with a portion of theproximal tibia. Outer sheath 30 extends from an entry point above thepatella along the femur and under the patella to engagement with aproximal portion of the tibia. If desired, a fixation plate may bepassed through sheath 30 for placement on the periosteal cortex of theproximal tibia. Alternatively, a guide wire 69 may be positioned throughsheath 30 into the intramedullary canal of the proximal tibia. A cuttinginstrument 44 such as a broach or awl may be advanced along guide wire69 to form an aperture through the proximal tibia and into theintramedullary canal. Sheath 30 may be utilized to provide a channel forevacuation of debris from the cutting site and to inhibit debris fromentering the knee joint. In one technique, a hole is formed in theproximal tibia approximating the diameter of sheath 30. The distal end34 such as shown in FIG. 2E may be advanced into the hole to firmlyengage the sheath 30 to the surrounding bone. In an alternativeprocedure, the embodiment of protective sheath 30 shown in FIG. 2D maybe utilized. In this procedure, imaging may be utilized to verify thatradiopaque marker 40 is in the proper position. Anchor pins 41 and 43may then be advanced distally to extend into the bone and affirmativelyengage the outer sheath 30 to the proximal portion of the tibia T.

Referring now to FIG. 7, intramedullary fixation plate 10 is advancedthrough outer sheath 30 into the proximal portion of tibia T. In apreferred aspect, guide wire 69 is inserted into bore 16 extending alongthe longitudinal axis of plate 10 to guide the plate into position.Plate 10 is grasped by plate holder 50 and is advanced along guide wire69 in the proximal tibia. It will be appreciated that plate holder 50may be rotated to adjust the rotational orientation of plate 10 withinouter sheath 30. Additionally, force may be applied to plate holder 50to adjust the longitudinal and rotational position of plate 10 withinthe intramedullary canal. Plate holder 50 may be fitted with a referencemarker 51 to permit an image-guided surgery system to approximate thelongitudinal and rotational position of fixation plate 10. Although notnecessarily drawn to scale in FIG. 7, it will be understood that plateholder 50 has a length that is substantially longer than the length ofprotective sheath 30 such that plate 10 may be fully positioned withinthe intramedullary canal of the proximal tibia and extended beyond thedistal portion 34 of sheath 30 with a substantial portion of plateholder 50 extending beyond proximal portion 32. If necessary, impactionforce may be applied to plate holder 50 to drive fixation plate 10 intoposition. Once fixation plate 10 has been properly positioned within theintramedullary canal of the proximal tibia, ring 61 may be rotated withrespect to outer tube 60 to thereby release hook 52 from plate 10. Afterthe plate holder 50 is disengaged from the plate 10, it may be withdrawnfrom outer sheath 30. Although a plate has been shown for the purpose ofillustration, an intramedullary rod may also be implanted utilizing theprocedures described above.

Referring now to FIG. 8, fixation members 26 and 28 may be positionedthrough fixation apertures 12 and 14 to fixedly connect theintramedullary plate to surrounding bone. It will be appreciated thatthe placement of fixation members 26 and 28 may be performed with theplate holder attached to assist in the alignment of the screw guideswith the fixation apertures 12 and 14, respectively. A mechanical guidemay be utilized that is joined to plate holder 50 to assist in theplacement of the fixation members. Alternatively or in combination,image-guided surgery may be utilized with reference marker 51 to providethe surgeon aiming guidance for positioning the fixation member directlythrough the aperture of the fixation plate. Any number of screws orother fixation members may be positioned through plate 10 as requiredfor the surgical procedure. Additionally, as best seen in FIG. 9,fixation members 26 and 28 may extend at non perpendicular anglesthrough the fixation apertures of plate 10. In the embodimentillustrated in FIG. 9, a fractured 74 is illustrated in the proximaltibia and fixation members 26 and 28 extend across the fraction into thedistal bone thereby fixing the proximal bone and distal portion to theintramedullary plate. Although not shown, a separate locking mechanismmay be provided with the plate to positively lock the fixation membersto the plate. Once the appropriate fixation members have been implanted,the protective sheath 30 and guide wire 69 may be removed from thepatient and the percutaneous puncture wound may be closed.

The foregoing description of the preferred embodiments of the presentinvention is intended to provide a teaching to those skilled in the art.The description is provided without limitation as to alternativefeatures and components that come within the scope of the invention.

What is claimed is:
 1. A method for insertion of a tibial fixationmember comprising: gaining supra patellar surgical access to anintramedullary canal of a proximal end of a tibia by creating a surgicalaccess site above the patella; moving the fixation member substantiallyposterior to the patella; inserting the fixation member into a proximalend of the intramedullary canal; providing a protective sheath with atleast one radiopaque marker; positioning the protective sheath to definea passage from the surgical access site into the intramedullary canal ofthe tibia; providing a guide wire with at least one radiopaque marker;passing the guide wire within the passage defined by the protectivesheath into the intramedullary canal; monitoring the position of theprotective sheath and guide wire by an image guidance system.
 2. Themethod of claim 1 wherein the image guidance system comprises an X-raydevice.
 3. A method for insertion of a tibial fixation membercomprising: creating a surgical access site above a patella; inserting asubstantially tubular protective sheath posterior to the patella suchthat a distal end is adjacent a proximal end of the tibia; accessing theintramedullary canal of the tibia utilizing a cutting tool guided by theprotective sheath; inserting the fixation member into a proximal end ofthe intradmedullary canal; and anchoring the fixation member to thetibia; wherein the fixation member defines a plurality of apertures forengaging bone engagement members; wherein inserting the fixation memberfurther comprises utilizing an insertion tool with an inner shaftthreaded to an outer tube on a proximal end and a gripping member on adistal end, the gripping member configured to releasably engage aproximal end of the fixation member.
 4. A method for percutaneousinsertion of a tibial fixation device, the method comprising: providinga sheath having a proximal portion, a distal portion, and an openingextending therebetween; creating a surgical access site above a patella;inserting the distal portion of the sheath through the surgical accesssite to a position adjacent a proximal portion of a tibia; inserting acutting tool through the sheath and utilizing the cutting tool to createan aperture to the intramedullary canal of the tibia; and inserting afixation device through the sheath into an intramedullary canal of thetibia; wherein the proximal portion of the sheath is positioned adjacenta thigh when the distal portion of the sheath is positioned adjacent theproximal portion of the tibia; wherein the fixation device is a plate.5. The method of claim 4 further comprising utilizing a guide wire toposition the plate within the intramedullary canal.
 6. The method ofclaim 5 further comprising inserting the guide wire through an openingextending along the length of the plate.
 7. The method of claim 6wherein the distal portion of the sheath includes a radiopaque marker,and wherein the positioning of the distal portion of the sheath adjacentthe proximal portion of the tibia comprises monitoring the position ofthe radiopaque marker using an imaging device.
 8. A method forpercutaneous fixation of a tibia, the method comprising: creatingsurgical access site above a patella; inserting a sheath through thesurgical access site such that a distal portion of the sheath ispositioned adjacent a proximal portion of the tibia; securing the distalportion of the sheath to the proximal portion of the tibia; removing asection of the proximal portion of the tibial to create an opening to anintramedullary canal of the tibia; inserting a fixation member throughthe sheath into the intradmedullary canal of the tibia; anchoring thefixation member; providing an instrument for selectively engaging thefixation member, the instrument having a flange member for selectivelyengaging an aperture of the fixation member; engaging the flange memberwith the aperture of the fixation member before inserting the fixationmember into the intramedullary canal; and releasing the flange memberfrom the aperture of the fixation member after inserting the fixationmember into the intramedullary canal.
 9. The method of claim 8 whereinanchoring the fixation member comprises extending a bone engagementdevice through the aperture in the fixation member.
 10. The method ofclaim 9 further comprising utilizing a guide wire to position thefixation member within the intramedullary canal.
 11. The method of claim10 further comprising inserting the guide wire through an openingextending along the length of the fixation member.